
Czech Republic has major updates in PV legislation
State Institute for Drug Control in Czech Republic (SÚKL) has released a new version of PHV-6 guideline (PHV-6 version 4) with the effect from 31st of January, 2025. The key points of the updated guideline include the requirements for reporting changes in the Pharmacovigilance System Master File (PSMF), for appointing the Qualified Person for Pharmacovigilance (QPPV) and for appointing the Local Person for Pharmacovigilance (LPPV) in the Czech Republic. It is important to note that the updated guideline is legally binding.
Requirements for reporting changes in the PSMF
MAHs are now obliged to inform SÚKL about a change in the PSMF, if the PSMF is located in the territory of the Czech Republic, within 7 calendar days. Changes required to be reported include change of the QPPV, contact details of the QPPV, PSMF location, name of the Marketing Authorization Holder (MAH) as well as if there is a new pharmacovigilance database or a new contractual/licensing partner who carries out some of the pharmacovigilance activities relevant for products in the Czech Republic. Moreover, SÚKL requires to report in case of any new patient program or register as well as critical and major findings after a completed PV system audit (internal or external).
Requirements for appointing QPPV
All MAHs are obliged to appoint QPPV and to provide his/her name, surname and contact details to SÚKL within 7 calendar days. The requirement applies regardless of the location of the PSMF. QPPV is required to reside and operate in the EU, Norway, Iceland or Liechtenstein. The appointed QPPV shall follow GVP I – Pharmacovigilance systems and their quality systems, in addition, SÚKL emphasizes that QPPV has to have theoretical and practical knowledge in pharmacovigilance as well as expertise in medicine, pharmaceutical sciences, epidemiology and biostatistics. In case QPPV does not have medical education, the MAH shall ensure that QPPV is assisted by a medically trained person and this assistance is properly documented.
Requirements for appointing LPPV
All MAHs are obliged to appoint LPPV in the Czech Republic and to notify this to SÚKL within 7 calendar days. The requirement applies regardless of the location of the PSMF. SÚKL highlights some criteria that LPPV should fulfill such as be able to communicate in Czech or Slovak language, be contactable on a phone number with the Czech country code and reside in the EU. The minimum responsibility of LPPV is to provide the contact between SÚKL and QPPV, however, QPPV and the LPPV may be the same person.
More information regarding the updated guideline can be found on SÚKL website: https://sukl.gov.cz/en/guidelines-pharmacovigilance-en/phv-6-version-4/